Sr Document Control Specialist
obotics & Digital Solutions, part of the Johnson & Johnson Family of companies, is recruiting for a Senior Document Control Specialist located in Santa Clara/San Jose, CA. A pre-identified candidate has been found for the role, however all other applicants will still be considered.
Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our dedication to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com
The Sr. Specialist will play an important role in implementing the document and change control processes for changes to Documents and Records in a Agile PLM system. This role is responsible for providing internal customers with mentorship in following document and change control procedures.
Key Responsibilities:
- Review changes in a timely manner for compliance with procedures.
- Select and/or verify required approvers of changes per procedures.
- Collaborate and provide mentorship to change owners, approvers, and business partners as needed.
- Collect and report metrics pertaining to change control activities.
- Communicate the status of changes.
- Lead small, prioritized projects that help support departmental objectives, including projects that require collaboration with other departments or facilities.
- Support and recommend change control process improvements including initiating procedural revisions.
- Support both internal and external audits, as well as quality events (CAPA, NC, Audit findings), relating to document/change control processes.
- Ensure all activities adhere to the documented quality system and current regulatory requirements.
